TELL THE FTC: Merck HPV Vaccine Television Commercial IS FALSE & MISLEADING

We, the undersigned, hereby submit to the US Federal Trade Commission this formal complaint that Merck, Inc. has, by and through its misleading television campaign for its product, a Gardisil™ vaccine, willfully misled the American public on the product’s capabilities and performance in protecting individuals against infection by the human papillomavirus (HPV) and from HPV-associated cancer, leading to possible injury due to product use.
The television advertisement, which has aired in various markets throughout the US, is composed of statements made by actors portraying adolescents who are represented as either having been infected with the HPV virus or have developed cancer from HPV infection.

This is the transcript of the television advertisement:

YFA: Young female actor
YMA: Young male actor
FVO: Female voice over
MVO: Male voice over
VO: Voice over
“FVO: I have cervical cancer from an infection; human papilloma virus.
Who knew HPV could lead to certain cancers?
Who knew my risk for HPV would increase as I got older?
Who knew that there was something that could have helped protect me from HPV when I was 11 or 12 way before I would even be exposed to it?
YFA: Did you know – Mom, Dad?
Still: Who knew HPV could cause certain cancers and diseases in girls? And boys.
MVO: I was infected with HPV. Maybe my parents didn’t know how widespread HPV is. While HPV clears up for most, that wasn’t the case for me. Maybe they didn’t know I would end up with cancer because of HPV. Maybe if they had known there was a vaccine to help protect me when I was 11 or 12, maybe my parents just didn’t know.
YMA: Right Mom, Dad?
VO: What will you say? Don’t wait. Talk to your child’s doctor today. Learn more at HPV.com”

The advertisement video is also available at http://www.hpvtvad.com.

The action of advertising unproven clinical performance characteristics is the same as making false claims of a product’s ability. The claims made by the ad are unwarranted given the totality of the evidence in the scientific literature. In claiming that HPV vaccines “could have” prevented HPV infection, Merck fails to inform the public of

(a) the knowledge that HPV vaccination does not protect against all HPV types, which could lead vaccinated consumers to act as though they are in fact protected from HPV infection in general, when, in reality, they are not;

(b) the knowledge that has resulted from numerous studies that indicate that HPV vaccination using any of the available HPV vaccines only provides partial protection against 2, 4 or 9 types of HPV, when in reality there are at least 100 HPV viral types that can replace those that the vaccination removes from an individual or from the population;

(c) the knowledge that women should continue to get Pap smears after HPV vaccination to screen for infection (as expected given type replacement);

(d) the knowledge that HPV vaccine has been found to fail to lead to a decrease in overall HPV infection rates, according to study by the US Centers for Disease Control and Prevention (Markowitz et al., 2016);

(e) the knowledge of side effects of HPV vaccination, including death, paralysis, premature ovarian failure, seizures and blindness;

(f) the knowledge of alternatives to the vaccines for protection against HPV;


(g) the knowledge that indiscriminate use of HPV vaccination in a population not screened for HPV infection may increase (double) the risk of HPV-associated cancer.

Via this advertisement, Merck is claiming that HPV vaccines “could have” prevented HPV-related cancers, a claim of their products’ performance beyond that supported by available research. Because HPV-induced cancers can take 20-40 years to manifest, no study has been conducted that demonstrates a decrease in the rates of overall HPV-related cancer types. The actor’s age is inconsistent with the age at which an HPV-associated cancer may be expected to appear.
In fact, grave concern exists that partial immunization for the most common HPV types may, via type replacement, lead to an increase in more lethal HPV types that are rare precisely because they are more lethal. No studies have shown a decrease in the rates of HPV-related cancers overall in humans.

The ad, and the website the advertisement points to, provides no indication of any possible serious, moderate, or mild side effects from HPV vaccine. Omitting the risks of HPV vaccine may cause some consumers of this product to conclude that HPV vaccination is risk-free, when experts have concluded that serious adverse events due to HPV vaccination occur at twice the rate of other vaccines.

We believe that Merck is in violation of truth in advertising laws that protect consumers against hidden fees and future non-disclosed required purchases. To attain full immunity, consumers will have to submit to additional medical procedures (further vaccination), and this is not disclosed.

We believe that Merck is guilty of “Angel-dusting”, in claiming that their product protects against “HPV infection” without specifying the types of HPV virus that their product does, and does not, provide protection against.

We believe that Merck is guilty of having undisclosed dishonest business practices regarding their involvement in legislative initiatives around the country to create mandates for their product.
We believe Merck is in violation of FTC rules by advertising unproven clinical efficacy without information on type replacement and side effects.

We ask that the FTC issue a cease and desist letter to Merck regarding this campaign, and to hold Merck, and any other pharmaceutical company accountable that fail to be fully transparent about the limits of the abilities of their advertised products and that make unsubstantiated claims about the abilities of their advertised products. Here we summarize the studies that demonstrate Merck’s misrepresentation of their product:

“The prevalence of high-risk nonvaccine types was higher among vaccinated women than unvaccinated women (52.1% vs 40.4%, prevalence ratio 1.29, 95% CI 1.06–1.57), but this difference was attenuated after adjusting for sexual behavior variables (adjusted prevalence ratio 1.19, 95% CI 0.99–1.43). HPV vaccination was effective against all 4 vaccine types in young women vaccinated after age 12. However, vaccinated women had a higher prevalence of high-risk nonvaccine types, suggesting that they may benefit from newer vaccines covering additional types” (Guo et al., 2015).

Mollers et al. (2014) found that partial immunization and HPV type clustering and spread foster conditions sufficient for HPV type replacement:

“The ecological niche could also be taken through type replacement, which refers to the possibility that elimination of HPV16 and HPV18 could lead to an increased transmission of nonvaccine types. For this to occur, antagonistic interactions are required between vaccine types and those not included in the vaccine (8, 9). Type replacement has been observed following vaccination against other pathogens (e.g., Streptococcus pneumoniae) (10) and is plausible whenever genotypically diverse pathogen strains compete for the same hosts” (Mollers et al., 2014).

A study of Italian women also found evidence of type replacement and recommended "an accurate post-vaccine surveillance is necessary to early detect a possible genotype replacement" (Giambi et al., 2013).
Perhaps the most compelling study showing HPV type replacement actually shows high-risk HPV type replacement. The study specifically found that high-risk HPV types replacing the vaccine-targeted types.

They reported:
“the percentage of non-vaccine HR-HPV types was higher than expected, considering that eight HPV types formerly classified as ‘low-risk’ or ‘probably high-risk’ are in fact HR-HPV types. (Fischer et al., 2016)”

There are other studies that show type replacement. While some studies may show no type replacement, negative results do not take precedence over positive results. At best, one could say that the science is unsettled. Remarkably, however, CDC's own study (Markowitz et al., 2016) showed no net change in HPV infection rate. This is cause for grave concern over the adequacy of HPV vaccines: while the vaccine-targeted types are cleared by their product, there are hundreds that can replace them across the sexually active population.

Serious adverse events are reported to occur at twice the rate of adverse events from other vaccines (Tomljenovic and Shaw, 2015).
A study in Vancouver, BC reported that as many as 1 in 10 girls may be injured by HPV vaccination (Liu et al., 2016).

Merck has never conducted safety studies in 11- and 12-year old children, and used "best guess" immunology and theories of extrapolation and ‘immune-bridging’ to decide the safety of the vaccine for this population (Merck, 2006). The long term study which the FDA requested during the approval process (the 10 year 2016 study) has not yet been done, therefore advertising this vaccine as done in the television ad before the 10-year study would seem to require a burden of proof beyond that actually provided by Merck.

We assert that Merck could very easily have voiced-over more complete, accurate and forthright information as required by FTC standards for products advertised and sold in the United States, such as:

“Patients should be screened for HPV infection prior to vaccination with Gardisil™ to avoid an increase in HPV-related cancers. Gardisil™ does not protect against all types of HPV: therefore women using Gardisil™ should still be screened using Pap smears. Individuals vaccinated with Gardisil™ should still practice safe-sex to avoid infection with types of HPV not targeted by Gardisil™. Individuals vaccinated with Gardisil™ may require further vaccination with future products to be protected against types of HPV that may emerge due to the clearance of more common vaccine-targeted types.”

We urge you to act immediately on these serious matters.

References

Fischer et al 2016: Shift in prevalence of HPV types in cervical cytology specimens in the era of HPV vaccination. Oncol Lett. 12(1):601-610. Full study: https://www.spandidos-publications.com/ol/12/1/601
Giambi C et al., 2013. A cross-sectional study to estimate high-risk human papillomavirus prevalence and type distribution in Italian women aged 18-26 years. BMC Infect Dis. 13:74. doi: 10.1186/1471-2334-13-74.
Guo, F et al., 2015. Comparison of HPV prevalence between HPV-vaccinated and non-vaccinated young adult women (20–26 years) Human Vaccines & Immunotherapeutics 11: Issue 10:11(10):2337-44. doi: 10.1080/21645515.2015.1066948.
Liu XC et al., 2016. Adverse events following HPV vaccination, Alberta 2006-2014. Vaccine. 34(15):1800-5. doi: 10.1016/j.vaccine.2016.02.040.
Markowitz LE et al., 2016 Prevalence of HPV After Introduction of the Vaccination Program in the United States. Pediatrics. 22. pii: peds.2015-1968.
Merck, 2006. Gardasil™ HPV Quadrivalent Vaccine May 18, 2006 VRBPAC Meeting, VRBPAC Background Document. http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf
Mollers M et al., 2014. Population- and type-specific clustering of multiple HPV types across diverse risk populations in the Netherlands. Am J Epidemiol. 179(10):1236-46. doi: 10.1093/aje/kwu038.
Tomljenovic, L, and CA. Shaw. 2015. Adverse Reactions to Human Papillomavirus Vaccines IN: VACCINES AND AUTOIMMUNITY Pages: 163–174, 2015 15 MAY 2015, DOI: 10.1002/9781118663721.ch17 http://amzn.to/2964403

We, the undersigned, hereby submit to the US Federal Trade Commission this formal complaint that Merck, Inc. has, by and through its misleading television campaign for its product, a Gardisil™ vaccine, willfully misled the American public on the product’s capabilities and performance in protecting individuals against infection by the human papillomavirus (HPV) and from HPV-associated cancer, leading to possible injury due to product use.
The television advertisement, which has aired in various markets throughout the US, is composed of statements made by actors portraying adolescents who are represented as either having been infected with the HPV virus or have developed cancer from HPV infection.


This is the transcript of the television advertisement:


YFA: Young female actor
YMA: Young male actor
FVO: Female voice over
MVO: Male voice over
VO: Voice over
“FVO: I have cervical cancer from an infection; human papilloma virus.
Who knew HPV could lead to certain cancers?
Who knew my risk for HPV would increase as I got older?
Who knew that there was something that could have helped protect me from HPV when I was 11 or 12 way before I would even be exposed to it?
YFA: Did you know – Mom, Dad?
Still: Who knew HPV could cause certain cancers and diseases in girls? And boys.
MVO: I was infected with HPV. Maybe my parents didn’t know how widespread HPV is. While HPV clears up for most, that wasn’t the case for me. Maybe they didn’t know I would end up with cancer because of HPV. Maybe if they had known there was a vaccine to help protect me when I was 11 or 12, maybe my parents just didn’t know.
YMA: Right Mom, Dad?
VO: What will you say? Don’t wait. Talk to your child’s doctor today. Learn more at HPV.com”


The advertisement video is also available at http://www.hpvtvad.com.


The action of advertising unproven clinical performance characteristics is the same as making false claims of a product’s ability. The claims made by the ad are unwarranted given the totality of the evidence in the scientific literature. In claiming that HPV vaccines “could have” prevented HPV infection, Merck fails to inform the public of


(a) the knowledge that HPV vaccination does not protect against all HPV types, which could lead vaccinated consumers to act as though they are in fact protected from HPV infection in general, when, in reality, they are not;


(b) the knowledge that has resulted from numerous studies that indicate that HPV vaccination using any of the available HPV vaccines only provides partial protection against 2, 4 or 9 types of HPV, when in reality there are at least 100 HPV viral types that can replace those that the vaccination removes from an individual or from the population;


(c) the knowledge that women should continue to get Pap smears after HPV vaccination to screen for infection (as expected given type replacement);


(d) the knowledge that HPV vaccine has been found to fail to lead to a decrease in overall HPV infection rates, according to study by the US Centers for Disease Control and Prevention (Markowitz et al., 2016);


(e) the knowledge of side effects of HPV vaccination, including death, paralysis, premature ovarian failure, seizures and blindness;


(f) the knowledge of alternatives to the vaccines for protection against HPV;



(g) the knowledge that indiscriminate use of HPV vaccination in a population not screened for HPV infection may increase (double) the risk of HPV-associated cancer.


Via this advertisement, Merck is claiming that HPV vaccines “could have” prevented HPV-related cancers, a claim of their products’ performance beyond that supported by available research. Because HPV-induced cancers can take 20-40 years to manifest, no study has been conducted that demonstrates a decrease in the rates of overall HPV-related cancer types. The actor’s age is inconsistent with the age at which an HPV-associated cancer may be expected to appear.
In fact, grave concern exists that partial immunization for the most common HPV types may, via type replacement, lead to an increase in more lethal HPV types that are rare precisely because they are more lethal. No studies have shown a decrease in the rates of HPV-related cancers overall in humans.


The ad, and the website the advertisement points to, provides no indication of any possible serious, moderate, or mild side effects from HPV vaccine. Omitting the risks of HPV vaccine may cause some consumers of this product to conclude that HPV vaccination is risk-free, when experts have concluded that serious adverse events due to HPV vaccination occur at twice the rate of other vaccines.


We believe that Merck is in violation of truth in advertising laws that protect consumers against hidden fees and future non-disclosed required purchases. To attain full immunity, consumers will have to submit to additional medical procedures (further vaccination), and this is not disclosed.


We believe that Merck is guilty of “Angel-dusting”, in claiming that their product protects against “HPV infection” without specifying the types of HPV virus that their product does, and does not, provide protection against.


We believe that Merck is guilty of having undisclosed dishonest business practices regarding their involvement in legislative initiatives around the country to create mandates for their product.
We believe Merck is in violation of FTC rules by advertising unproven clinical efficacy without information on type replacement and side effects.


We ask that the FTC issue a cease and desist letter to Merck regarding this campaign, and to hold Merck, and any other pharmaceutical company accountable that fail to be fully transparent about the limits of the abilities of their advertised products and that make unsubstantiated claims about the abilities of their advertised products. Here we summarize the studies that demonstrate Merck’s misrepresentation of their product:


“The prevalence of high-risk nonvaccine types was higher among vaccinated women than unvaccinated women (52.1% vs 40.4%, prevalence ratio 1.29, 95% CI 1.06–1.57), but this difference was attenuated after adjusting for sexual behavior variables (adjusted prevalence ratio 1.19, 95% CI 0.99–1.43). HPV vaccination was effective against all 4 vaccine types in young women vaccinated after age 12. However, vaccinated women had a higher prevalence of high-risk nonvaccine types, suggesting that they may benefit from newer vaccines covering additional types” (Guo et al., 2015).


Mollers et al. (2014) found that partial immunization and HPV type clustering and spread foster conditions sufficient for HPV type replacement:


“The ecological niche could also be taken through type replacement, which refers to the possibility that elimination of HPV16 and HPV18 could lead to an increased transmission of nonvaccine types. For this to occur, antagonistic interactions are required between vaccine types and those not included in the vaccine (8, 9). Type replacement has been observed following vaccination against other pathogens (e.g., Streptococcus pneumoniae) (10) and is plausible whenever genotypically diverse pathogen strains compete for the same hosts” (Mollers et al., 2014).


A study of Italian women also found evidence of type replacement and recommended "an accurate post-vaccine surveillance is necessary to early detect a possible genotype replacement" (Giambi et al., 2013).
Perhaps the most compelling study showing HPV type replacement actually shows high-risk HPV type replacement. The study specifically found that high-risk HPV types replacing the vaccine-targeted types.


They reported:
“the percentage of non-vaccine HR-HPV types was higher than expected, considering that eight HPV types formerly classified as ‘low-risk’ or ‘probably high-risk’ are in fact HR-HPV types. (Fischer et al., 2016)”


There are other studies that show type replacement. While some studies may show no type replacement, negative results do not take precedence over positive results. At best, one could say that the science is unsettled. Remarkably, however, CDC's own study (Markowitz et al., 2016) showed no net change in HPV infection rate. This is cause for grave concern over the adequacy of HPV vaccines: while the vaccine-targeted types are cleared by their product, there are hundreds that can replace them across the sexually active population.


Serious adverse events are reported to occur at twice the rate of adverse events from other vaccines (Tomljenovic and Shaw, 2015).
A study in Vancouver, BC reported that as many as 1 in 10 girls may be injured by HPV vaccination (Liu et al., 2016).


Merck has never conducted safety studies in 11- and 12-year old children, and used "best guess" immunology and theories of extrapolation and ‘immune-bridging’ to decide the safety of the vaccine for this population (Merck, 2006). The long term study which the FDA requested during the approval process (the 10 year 2016 study) has not yet been done, therefore advertising this vaccine as done in the television ad before the 10-year study would seem to require a burden of proof beyond that actually provided by Merck.


We assert that Merck could very easily have voiced-over more complete, accurate and forthright information as required by FTC standards for products advertised and sold in the United States, such as:


“Patients should be screened for HPV infection prior to vaccination with Gardisil™ to avoid an increase in HPV-related cancers. Gardisil™ does not protect against all types of HPV: therefore women using Gardisil™ should still be screened using Pap smears. Individuals vaccinated with Gardisil™ should still practice safe-sex to avoid infection with types of HPV not targeted by Gardisil™. Individuals vaccinated with Gardisil™ may require further vaccination with future products to be protected against types of HPV that may emerge due to the clearance of more common vaccine-targeted types.”


We urge you to act immediately on these serious matters.


References


Fischer et al 2016: Shift in prevalence of HPV types in cervical cytology specimens in the era of HPV vaccination. Oncol Lett. 12(1):601-610. Full study: https://www.spandidos-publications.com/ol/12/1/601
Giambi C et al., 2013. A cross-sectional study to estimate high-risk human papillomavirus prevalence and type distribution in Italian women aged 18-26 years. BMC Infect Dis. 13:74. doi: 10.1186/1471-2334-13-74.
Guo, F et al., 2015. Comparison of HPV prevalence between HPV-vaccinated and non-vaccinated young adult women (20–26 years) Human Vaccines & Immunotherapeutics 11: Issue 10:11(10):2337-44. doi: 10.1080/21645515.2015.1066948.
Liu XC et al., 2016. Adverse events following HPV vaccination, Alberta 2006-2014. Vaccine. 34(15):1800-5. doi: 10.1016/j.vaccine.2016.02.040.
Markowitz LE et al., 2016 Prevalence of HPV After Introduction of the Vaccination Program in the United States. Pediatrics. 22. pii: peds.2015-1968.
Merck, 2006. Gardasil™ HPV Quadrivalent Vaccine May 18, 2006 VRBPAC Meeting, VRBPAC Background Document. http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf
Mollers M et al., 2014. Population- and type-specific clustering of multiple HPV types across diverse risk populations in the Netherlands. Am J Epidemiol. 179(10):1236-46. doi: 10.1093/aje/kwu038.
Tomljenovic, L, and CA. Shaw. 2015. Adverse Reactions to Human Papillomavirus Vaccines IN: VACCINES AND AUTOIMMUNITY Pages: 163–174, 2015 15 MAY 2015, DOI: 10.1002/9781118663721.ch17 http://amzn.to/2964403

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